New Approvals for Late May

The FDA has approved the following products:

  • GlaxoSmithKline’s Entereg:

    Entereg (alvimopan) is a peripherally-acting mu opioid receptor (PAM-OR) antagonist designed to block the adverse side effects of opioid analgesics on the GI tract without blocking their beneficial analgesic effects.

  • Tentative approval for Teva’s Lansoprazole, the generic equivalent of Prevacid.
  • Tentative approval for both Cobalt Labs and Ivax’s Topiramate, the generic equivalent of Topamax.
  • Tentative approval for Apotex’s Escitalopram oxalate, the generic equivalent of Lexapro.

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